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Effects of Exercise Training in Chronic Obstructive Pulmonary Disease Versus Alpha-1-Antitrypsin-deficiency-patients

Primary Purpose

Chronic Obstructive Pulmonary Disease, Alpha-1-antitrypsin-deficiency

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
exercise training
Sponsored by
Schön Klinik Berchtesgadener Land
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Chronic Obstructive Pulmonary Disease focused on measuring alpha-1-antitrypsin-deficiency, COPD, exercise training, muscle biopsy

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • COPD
  • Alpha-1-Antitrypsine-deficiency, phenotype: ZZ
  • FEV1%pred. <50

Exclusion Criteria:

  • acute exacerbation
  • exacerbation in the last 4 weeks

Sites / Locations

  • Klinikum Berchtesgadener Land

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

exercise training

Arm Description

Outcomes

Primary Outcome Measures

aerobic and anaerobic enzymes
changes in quantity of enzymes from baseline to day 23

Secondary Outcome Measures

maximal exercise capacity in incremental cycling test
Change in max. exercise capacity from baseline to day 23
6-minute-walking distance
change in 6-minute-walking distance from baseline to day 24

Full Information

First Posted
June 22, 2011
Last Updated
December 16, 2013
Sponsor
Schön Klinik Berchtesgadener Land
Collaborators
Grifols Therapeutics LLC, Alpha-1 Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01380626
Brief Title
Effects of Exercise Training in Chronic Obstructive Pulmonary Disease Versus Alpha-1-Antitrypsin-deficiency-patients
Official Title
Effects of Exercise Training on Quadriceps Gene Expression in COPD-patients in Comparison to Alpha-1-Antitrypsin-deficiency-patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Schön Klinik Berchtesgadener Land
Collaborators
Grifols Therapeutics LLC, Alpha-1 Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Chronic Obstructive Pulmonary Disease (COPD)-patients (caused by smoking-level) and Alpha-1-Antitrypsin-deficiency patients showed different developments during rehabilitation in regard to improvement of 6-minute-walking distance. The aim of this study is to investigate differences between training adaptations in COPD-patients and Alpha-1-deficiency patients. Both groups take part in a standardized multimodal 3-week-rehabilitation with strength and endurance training. In addition to conventional diagnostic procedures, muscle biopsies from the M. vastus lateralis will be conducted before and after rehabilitation program followed by biochemical, histochemical and immunohistochemical analysis of the probes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Alpha-1-antitrypsin-deficiency
Keywords
alpha-1-antitrypsin-deficiency, COPD, exercise training, muscle biopsy

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
exercise training
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
exercise training
Other Intervention Name(s)
endurance training, strength training
Intervention Description
strength and endurance training, 5 time per week.
Primary Outcome Measure Information:
Title
aerobic and anaerobic enzymes
Description
changes in quantity of enzymes from baseline to day 23
Time Frame
day 2 and 23
Secondary Outcome Measure Information:
Title
maximal exercise capacity in incremental cycling test
Description
Change in max. exercise capacity from baseline to day 23
Time Frame
day 2 and 23
Title
6-minute-walking distance
Description
change in 6-minute-walking distance from baseline to day 24
Time Frame
day 3 and 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: COPD Alpha-1-Antitrypsine-deficiency, phenotype: ZZ FEV1%pred. <50 Exclusion Criteria: acute exacerbation exacerbation in the last 4 weeks
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus Kenn, Dr. med.
Organizational Affiliation
Klinikum Berchtesgadener Land, Schön Klinik
Official's Role
Study Chair
Facility Information:
Facility Name
Klinikum Berchtesgadener Land
City
Berchtesgaden
ZIP/Postal Code
83471
Country
Germany

12. IPD Sharing Statement

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Effects of Exercise Training in Chronic Obstructive Pulmonary Disease Versus Alpha-1-Antitrypsin-deficiency-patients

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